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Notable Changes in the new FDA Draft Guidance – Content of Premarket Submissions for Device Software Functions The FDA released its new draft guidance for the Content of Premarket Submissions for Device Software Functions on November 4, 2021. Once approved, this guidance will replace the preexisting Guidance for the Content of Premarket Submissions for Software […]
What is the Urgency Behind Automotive Cybersecurity? From a Market Perspective: As automobiles are growing increasingly connected, digitized, and complex, automotive cybersecurity has become top of mind. Made up of hundreds of “tiny computers” – each with its own networks and servers – a singular vehicle is open to millions of opportunities for cyber-attack. In […]
Design Transfer: Best Practices for Translating Your Device Design into Manufacturing Specifications Manufacturing specifications are successful when they result in your medical device being produced consistently, over and over, and meet requirements and expectations, including those of design intent and quality specifications. In this blog post, I’ll share the best practices I follow when translating […]
This is part 2 of a two-part blog series covering our eBook, “A Complete Guide to Automotive Safety Integrity Levels (ASIL)“, in which we discuss this important automotive safety standard and how to comply with it. Part 1 can be found HERE and the entire eBook can be downloaded HERE. A Complete Guide to Automotive […]
In this blog, we recap an episode from the eVOTL Insights Podcast, titled “Episode 75: Cary Bryczek, Director of Solutions for A&D, Jama Software.” Certification and the Role It Plays in the eVTOL Aircraft Market eVTOL Insights is a leading source of news, information and analysis into the global electric vertical take-off and landing (eVTOL) […]
This is part 1 of a two-part blog series covering our eBook, “A Complete Guide to Automotive Safety Integrity Levels (ASIL)” in which we discuss this important automotive safety standard and how to comply with it. We will share the link to part 2 when it publishes. In the meantime, you can download the eBook […]
In this post, we highlight and summarize parts of the new “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions Draft Guidance for Industry and Food and Drug Administration Staff.” It is important to note that this content contains non-binding guidance and therefore is not currently for implementation. With that said, while […]
> In this blog, we preview our whitepaper “FDA New Draft Guidance of Premarket Submissions for Medical Devices: Are you ready?” Download the entire whitepaper to learn more! FDA New Draft Guidance of Premarket Submissions for Medical Devices: Are you ready? Technology innovation has undergone rapid transformation since the Food and Drug Administration first developed its […]
In this blog, we recap the “Moving from Modules to Models – Is it finally time to leave IBM® DOORS® behind?” webinar. As products grow increasingly complex, many teams are asking themselves if they have become complacent in how we approach requirements management and the value it delivers. Regardless of the industry, requirements are critical […]
In this blog, we preview our eBook IEC 61508 Overview: The Complete Guide for Functional Safety in Industrial Manufacturing. Download the entire eBook to learn more! IEC 61508 Overview: The Complete Guide for Functional Safety in Industrial Manufacturing Industrial manufacturing firms are undergoing rapid transformation as they navigate talent shortages, supply disruptions, digital adoption acceleration, […]